Actively Recruiting
A Phase I, Open-label, Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of Oral HS-10382 in Patients With Chronic Myeloid Leukemia
Led by Jiangsu Hansoh Pharmaceutical Co., Ltd. · Updated on 2023-01-13
108
Participants Needed
1
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating HS-10382, an oral small molecule that inhibits the BCR-ABL1 protein by locking it into an inactive form, in patients with chronic myeloid leukemia (CML). This study focuses on patients with CML in chronic or accelerated phases, including those with the T315I mutation. The goal is to investigate the safety, how the drug moves through the body, and its effect on CML, especially in those resistant or intolerant to previous treatments. This open-label study has two parts: a dose escalation phase with five increasing dose groups to find the safest and most effective dose, followed by a dose expansion phase to further assess safety and efficacy at the recommended dose. Participants receive HS-10382 orally once daily in both phases. Patients will be monitored closely for side effects and disease status, with the option to continue treatment if the drug is tolerated and disease remains stable or improves. During the study, participants will undergo regular assessments including blood tests to measure hematologic, molecular, and cytogenetic responses at specified intervals. Safety will be monitored continuously during treatment and for 28 days after the last dose. Researchers will also track how the drug is absorbed and processed in the body. Outcome measures include maximum tolerated dose, response rates at 6 months, and long-term survival outcomes up to 24 months. The total study may last several months with ongoing safety and efficacy evaluations.
CONDITIONS
Brief Title
A Study of HS-10382 in Patients With Chronic Myeloid Leukemia.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form.
- Men or women aged 18 years or older and younger than 75 years.
- Diagnosed with chronic myeloid leukemia in chronic or accelerated phase with the Philadelphia chromosome or BCR-ABL1 fusion gene.
- Resistant to or intolerant of previous tyrosine kinase inhibitor therapy.
- ECOG performance status of 0 to 2.
- Life expectancy of at least 12 weeks.
- Use of adequate contraceptive measures throughout the study; females must not be breastfeeding during the study and for 6 months after.
- Females must have evidence of non-childbearing potential.
You will not qualify if you...
- Chronic phase CML patients who have acquired complete cytogenetic response and have not lost it.
- Chronic phase CML patients who have progressed to accelerated or blast phase.
- Accelerated phase CML patients who have achieved complete hematologic response or show no evidence of CML in peripheral blood.
- Accelerated phase CML patients who have progressed to blast phase.
- Previous treatment with a BCR-ABL1 tyrosine kinase inhibitor allosteric inhibitor.
- Impaired cardiac function including prolonged QTc interval, abnormal heart rhythm, low ejection fraction (≤50%), low heart rate (<50 bpm), recent myocardial infarction or heart failure, or uncontrollable angina.
- History of acute pancreatitis within 1 year or chronic pancreatitis.
- Severe or uncontrolled systemic diseases such as uncontrolled hypertension or diabetes.
- Severe gastrointestinal dysfunction affecting drug intake or absorption.
- Severe infection within 4 weeks prior to first dose.
- History of significant bleeding disorders unrelated to CML.
- Inadequate function of other organs.
- History of other malignancies.
- Hypersensitivity to any component of HS-10382.
- History of neuropathy or mental disorders including epilepsy and dementia.
- Investigator judgment that patient is unlikely to comply with study procedures or requirements.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 35 days in dose escalation; longer in dose expansion as determined by study protocol
Participants receive oral HS-10382 once daily in a dose escalation or dose expansion regimen to evaluate safety, tolerability, and preliminary anti-CML activity.
Multiple visits during treatment cycles with assessments on Day 1 through Day 35 in dose escalation and regular visits during dose expansion
Duration - 28 days after last dose
Participants are followed for adverse events and safety monitoring for 28 days after the last dose of study drug.
1 to 2 visits after treatment ends depending on individual participant status
Trial Site Locations
Total: 1 location
1
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Actively Recruiting
Research Team
Y
Yu Hu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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